NCT01897519

Brief Summary

This study will evaluate the safety and efficacy of ABT-719 in patients undergoing high risk major surgery.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2013

Shorter than P25 for phase_2

Geographic Reach
2 countries

23 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 6, 2014

Status Verified

June 1, 2014

Enrollment Period

1 year

First QC Date

May 10, 2013

Last Update Submit

June 5, 2014

Conditions

Cardiothoracic SurgeryVascular Surgery

Keywords

High risk surgeryAcute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Change in urine Neutrophil Gelatinase-Associated Lipocalin (NGAL)

    Comparison between each ABT-719 dose group versus placebo in the mean maximal change from baseline in urine NGAL from Day 0 - Day 7.

    Day 0 to Day 7

Secondary Outcomes (4)

  • Proportion of subjects that develop composite event at 90 days post surgery

    90 Day

  • Proportion of subjects that develop a composite event at 60 days post surgery

    60 Days

  • Proportion of subjects that develop the Acute Kidney Injury Network (AKIN) scoring criteria

    Day 7

  • Proportion of subjects that develop the Kidney Disease Improving Global Outcomes (KDIGO) scoring criteria

    Day 7

Study Arms (4)

Arm 1 lower dose ABT-719

EXPERIMENTAL
Drug: ABT-719

Arm 2 intermediate dose ABT-719

EXPERIMENTAL
Drug: ABT-719

Arm 3 high dose ABT-719

EXPERIMENTAL
Drug: ABT-719

Arm 4 Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

Placebo infusion

Arm 4 Placebo
ABT-719DRUG

Arm 1 lower dose, arm 2 intermediate dose, arm 3 high dose

Arm 1 lower dose ABT-719Arm 2 intermediate dose ABT-719Arm 3 high dose ABT-719

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients undergoing high risk major surgery in subjects with cardiovascular disease who are at risk of AKI.

You may not qualify if:

  • Ongoing or recent history of sepsis
  • Has recent documented acute kidney injury.
  • Subject is scheduled to have a total or partial nephrectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Site Reference ID/Investigator# 96295

Gainesville, Florida, 32610, United States

Location

Site Reference ID/Investigator# 96778

Jacksonville, Florida, 32207, United States

Location

Site Reference ID/Investigator# 96301

Tampa, Florida, 33613, United States

Location

Site Reference ID/Investigator# 96302

Fort Wayne, Indiana, 46804, United States

Location

Site Reference ID/Investigator# 101961

Indianapolis, Indiana, 46237, United States

Location

Site Reference ID/Investigator# 103356

Boston, Massachusetts, 02115, United States

Location

Site Reference ID/Investigator# 96303

Boston, Massachusetts, 02135, United States

Location

Site Reference ID/Investigator# 96997

Grand Blanc, Michigan, 48439, United States

Location

Site Reference ID/Investigator# 97878

Petoskey, Michigan, 49770, United States

Location

Site Reference ID/Investigator# 99377

Royal Oak, Michigan, 48073, United States

Location

Site Reference ID/Investigator# 99317

West Orange, New Jersey, 07052, United States

Location

Site Reference ID/Investigator# 96996

New York, New York, 10032, United States

Location

Site Reference ID/Investigator# 96296

Durham, North Carolina, 27710, United States

Location

Site Reference ID/Investigator# 102020

Cleveland, Ohio, 44195, United States

Location

Site Reference ID/Investigator# 103355

Columbus, Ohio, 43210, United States

Location

Site Reference ID/Investigator# 97556

Pittsburgh, Pennsylvania, 15232, United States

Location

Site Reference ID/Investigator# 103316

Providence, Rhode Island, 02903, United States

Location

Site Reference ID/Investigator# 102019

Memphis, Tennessee, 38120, United States

Location

Site Reference ID/Investigator# 108255

Charlottesville, Virginia, 22908, United States

Location

Site Reference ID/Investigator# 96300

Milwaukee, Wisconsin, 53215, United States

Location

Site Reference ID/Investigator# 105755

Aarhus N, 8200, Denmark

Location

Site Reference ID/Investigator# 105757

Kolding, 6000, Denmark

Location

Site Reference ID/Investigator# 105756

Odense C, 5000, Denmark

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

ABT 719

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Ann Eldred, MD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2013

First Posted

July 12, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 6, 2014

Record last verified: 2014-06

Locations

DK(3)US(20)